On October 9, 2024 Akiram Therapeutics reported that it has developed 177Lu-AKIR001, a new type of targeted radioimmunotherapy (Press release, Akiram Therapeutics, OCT 9, 2024, View Source [SID1234647279]). The therapy holds the potential to become a first-in-class treatment in multiple cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer. The drug is composed of a target recognition molecule to which therapeutic radioactivity is coupled for effect on tumor cells.

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The presentations at the EANM Congress will focus on the development and optimization of the drug in preparation for upcoming clinical trials. Specifically, the cGMP production process, which ensures the drug can be manufactured according to high-quality standards for clinical studies, will be highlighted.

The presentation on the cGMP development of 177Lu-AKIR001 has been selected as one of the Top-Rated Oral Presentations at the congress:

Title: cGMP development of the 177Lu-AKIR001 for clinical translation in first-in-human studies of CD44v6 expressing cancer patients
Presentation No.: OP-082
Date & Time: October 20, 9:45 AM, Hall X1-X4
Speaker: Klas Bratteby

Additionally, several other key research findings on 177Lu-AKIR001 will be showcased as posters, including:

177Lu-AKIR001 inhibits growth of pancreatic tumour xenografts
Poster No.: EP-0100
Presented by: Amanda Gustafsson
Fractionation of 177Lu-DOTA-AKIR001 results in increased curative rates and favorable hematopoietic toxicities compared to single high dose
Poster No.:EP-0992
Presented by: Anja Mortensen
Biodistribution and in vivo efficacy of 161Tb-labeled AKIR001, a novel anti-CD44v6 antibody
Poster No.: EP-0991
Presented by: Anja Mortensen
"We are thrilled to see the results of our academic collaborations presented at the EANM Congress. 177Lu-AKIR001 has shown great preclinical potential to transform the treatment of CD44v6-expressing tumors. We are looking forward to starting phase 1 studies later this fall, with the goal of offering new, targeted treatment options for patients with hard-to-treat cancers," says Marika Nestor, CEO of Akiram Therapeutics. "The selection of the cGMP production presentation as one of the top-rated talks is a clear recognition of the promising research, and we are excited to share the results with the international scientific community."

EANM – The European Association of Nuclear Medicine
The annual EANM Congress is one of the premier global platforms where leading experts and industry representatives from around the world gather to discuss advancements and future trends in nuclear medicine. Read more: View Source

About Akiram’s Drug Candidate
Developed through antibody phage display and affinity maturation targeting the CD44v6 cancer marker, 177Lu-AKIR001 combines the radiation component lutetium-177 with a targeted molecule. Preclinical studies have demonstrated its potential as a promising, first-in-class radiopharmaceutical therapy for cancers with high CD44v6 expression.

On October 9, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, reported that pharmacokinetic data for evaluation of AU-007 in the Phase 2 portion of its Phase 1/2 clinical trial will be presented at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (Press release, Aulos Bioscience, OCT 9, 2024, View Source [SID1234647104]). AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors in patients with unresectable locally advanced or metastatic cancers. The EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) symposium is being held October 23-25, 2024, in Barcelona, Spain.

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"With the Phase 1 trial of AU-007 completing the dose escalation and expansion phase, we are pleased to share the pharmacokinetic data used to determine dose selection of AU-007 for the Phase 2 portion of the trial," said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer. "We’re excited by the continued progress and distinct findings with our investigational therapy in the clinic, and we are grateful to the clinicians and patients who participate in this important study."

Details of the poster presentation are as follows:

Poster Number and Title: PB452: Determination of the phase 2 dose of AU-007, an AI-designed human monoclonal antibody that redirects IL-2 to T effector cells
Abstract: 464
Session: New therapies in immuno oncology
Session Date and Time: Friday, October 25, 2024, 9:00 a.m.-3:00 p.m. CEST

The poster will be presented in the Exhibition Hall at the Centre de Convencions Internacional de Barcelona (CCIB).

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

On October 9, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; "Zai Lab") reported that data from a Phase 1 study of ZL-1310, the Company’s investigational antibody-drug conjugate (ADC), will be presented during a plenary session at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium (ENA) 2024 taking place October 23-25, in Barcelona, Spain (Press release, Zai Laboratory, OCT 9, 2024, View Source [SID1234647122]). The preliminary results from the ongoing, open-label, multicenter clinical trial (NCT06179069) will address the potential of ZL-1310 as a novel treatment for small cell lung cancer (SCLC).

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DLL3 is overexpressed in many neuroendocrine tumors, including SCLC, and is typically associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 antibody and a novel camptothecin derivative as its payload. The compound was designed with a novel linker-payload platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

"New therapies that reduce off-target toxicity and increase anti-tumor effectiveness are critically needed to improve treatment options for many cancer patients, including SCLC and other tumors of neuroendocrine origin," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "ZL-1310 is an example of our company’s commitment to progressing a differentiated global oncology pipeline that will help fill these types of treatment gaps and provide meaningful benefit to patients. We look forward to sharing preliminary results from the Phase 1 study of this exciting next-generation ADC at ENA 2024."

Details regarding the ZL-1310 oral presentation at ENA 2024 are as follows:

Title: Preliminary Results from a Phase 1a/1b, Open-Label, Multicenter Study of ZL-1310, a DLL3-targeted ADC, to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer
Abstract Number: ENA24-0345
Presenter: Alex Spira, MD, PhD, FACP, FASCO, Virginia Cancer Specialists, Fairfax, VA
Presentation Date and Time: Thursday, October 24, 2024, 11:12 a.m. – 11:24 a.m. CET (presentation), 11:24 a.m. – 11:30 a.m. CET (Q&A)
Location: Centre de Convencions Internacional de Barcelona (CCIB), Room 111 and 112

On October 9, 2024 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, reported the publication of new research in the peer-reviewed journal Cell Reports supporting the potential of BullFrog AI’s drug candidate, BF-114 (SPTBN1 siRNA), in treating a range of liver diseases, including metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction-associated steatohepatitis (MASH), and hepatocellular carcinoma (HCC) (Press release, Bullfrog AI, OCT 9, 2024, View Source [SID1234647105]). The research was generated in a study led by Lopa Mishra, MD, professor of medicine, Merinoff Endowed Chair and co-director of the Institute for Bioelectronic Medicine at Feinstein Institutes for Medical Research at Northwell Health, Cold Spring Harbor Laboratory.

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"This research strengthens the scientific foundation for BF-114 and its potential role in addressing complex liver diseases," said Vin Singh, CEO of BullFrog AI. "Dr. Mishra’s work offers compelling evidence that our approach could change the treatment landscape for these metabolic disorders."

Dr. Mishra’s research demonstrates that β2-spectrin, a protein encoded by the SPTBN1 gene, mediates the effects of environmental factors that drive the progression of MASH. By reducing β2-spectrin levels, BF-114 has been shown to halt the progression of MASLD and MASH in animal models, while also reducing liver damage.

These findings strengthen and extend previously published data from Dr. Mishra’s laboratory that support BullFrog AI’s development of BF-114 for the treatment of obesity and liver diseases.

BullFrog AI plans to leverage its proprietary AI-driven platform to analyze single-cell data from animal models and human patients. This analysis will provide additional mechanistic understanding of the effects of SPTBN1 silencing in obesity and liver disease. The insights gained are expected to inform the continued development of BF-114 and may potentially reveal additional therapeutic applications.

BullFrog AI is also pleased to welcome Dr. Mishra to its Scientific Advisory Board. Dr. Mishra will provide guidance as the Company advances its BF-114 program. Dr. Mishra received her MBBS from the University of London and completed fellowships in Medicine and Gastroenterology at Royal Northern/Whittington Hospital (London), Mount Sinai Medical Center, and Johns Hopkins Hospital. With over 100 peer-reviewed publications relevant to the field and an H-Index of 66, her expertise will be instrumental in guiding the continued development of BF-114.

Dr. Mishra commented, "I am excited to join BullFrog AI’s Scientific Advisory Board and continue our work in targeting SPTBN1. The combination of BullFrog AI’s approach to drug development and the promising results we’ve seen with BF-114 provides a strong foundation for the continued exploration of its potential in treating obesity and liver diseases. I look forward to contributing to the advancement of BF-114 and exploring its multiple therapeutic possibilities."

On October 9, 2024 Exscientia plc (Nasdaq: EXAI) reported three abstracts to be presented at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium 2024 from October 23-25, in Barcelona, Spain (Press release, Exscientia, OCT 9, 2024, View Source [SID1234647123]).

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"As our precision-designed LSD1 and MALT1 inhibitors continue to progress towards the clinic, we are excited to share new preclinical data from both programmes," said David Hallett, Ph.D., interim Chief Executive Officer and Chief Scientific Officer of Exscientia. "These posters, as well as an additional focus on our assay development, highlight the potential of our platform to design best-in-class molecules with improved properties. As our state-of-the-art automation facility continues to ramp up in scale, we look forward to further accelerating the design and development of future molecules."

The ENA posters will be available on the Exscientia website from their time of presentation.

Poster Presentations
Title: Combining next-generation BTK and MALT1 inhibitors to enhance efficacy and therapeutic utility in B-cell malignancies
Session Title: Combination therapies
Catalog Number: 218
Poster Board Number: PB206
Date/Time: Thursday, October 24 / 9:00 a.m. – 5:30 p.m. CEST

EXS73565 (‘565) is a potent, selective allosteric MALT1 inhibitor designed to have an improved safety profile, with clinical studies expected to start in early 2025
Combining MALT1 inhibitors, such as ‘565, with BTK inhibitors has the potential to provide enhanced efficacy in B-cell malignancies, by greater inhibition of pathogenic nuclear factor-kappa B (NF-kB) signalling and addressing BTK-resistance mechanisms
Exscientia researchers combined ‘565 with the BTK inhibitor zanubrutinib and observed deeper, more durable efficacy responses in xenograft models of B-cell malignancies, with long-lasting tumour eradication seen for activated B-cell-like diffuse large B-cell lymphoma (ABC-DLBCL)
Studies also confirmed target pathway biology engagement, with ‘565 alone and in combination with zanubrutinib inhibiting NF-kB target gene expression in in vivo models
Overall, the selective profiles of ‘565 and zanubrutinib may maximise the therapeutic index of MALT1 and BTK inhibition in combination, providing scope for enhanced efficacy for patients with B-cell malignancies
Title: In vivo pharmacokinetics, pharmacodynamics and anti-tumour efficacy of EXS74539: A novel, reversible LSD1 inhibitor for acute myeloid leukaemia
Session Title: Epigenetic modulators (HDAC bromodomain modulators, EZH2)
Catalog Number: 250
Poster Board Number: PB238
Date/Time: Thursday, October 24 / 9:00 a.m. – 5:30 p.m. CEST

‘539 is a novel, potent, selective and reversible LSD1 inhibitor, with a highly differentiated profile and designed to be brain penetrant, expected to enter the clinic in early 2025
The poster highlights that by combining ex vivo perturbation of primary human acute myeloid lymphoma (AML) samples with ‘539 and omics profiling, 12 potential pharmacodynamic (PD) biomarker gene candidates were identified that correlate with LSD1 inhibitor activity
Upregulation of the identified biomarker gene candidates was confirmed in an in vivo AML xenograft model post ‘539 treatment
Treatment of the in vivo model with the reversible inhibitor ‘539 resulted in limited platelet level effects, highlighting how ‘539 was designed to maximise target engagement while limiting thrombocytopenia
Title: Xcellomics: Powering rapid translation of HTS outputs to AI-driven drug discovery programmes
Session Title: Functional genomics
Catalog Number: 414
Poster Board Number: PB402
Date/Time: Friday, October 25 / 9:00 a.m. – 3:00 p.m. CEST

Xcellomics is a collaboration between Exscientia and The Centre for Medicines Discovery at the University of Oxford, used to rapidly translate the results of cell-based, high-throughput screens into transformative oncology therapies
The collaboration has successfully identified and validated novel essential regulators of a key oncogenic pathway
Automated assay development and chemical hit ID performed by Exscientia rapidly pushed these novel therapeutic targets into drug discovery programmes